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Engineering Support Specialist

North Potomac, MD 20878

Posted: 03/24/2023 Employment Type: Contract Job Category: Engineering Job Number: 552772 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 30-47.85/hr **salary will be commensurate with experience 

Job Description:

The candidate will work with combination products and the associated life-cycle maintenance activities. This includes Design Transfers, Periodic Risk Review Reports, Design History File (DHF) Remediation and commercial manufacturing support. Activities may include:
  • Performing gap assessments on existing DHFs against SOPs and standards
  • Updating relevant documents within the DHF
  • Performing impact assessments for design changes
  • Managing Change Controls and driving the implementation of the necessary activities for the change
  • Analyzing complaints and compiling relevant data for the annual risk review
  • Working with different functions such as; device development, device quality, drug product, packaging, and human factors

This position is located in the Drug Product Combination Product Global Technical Operations group located in Gaithersburg, MD. Working remotely is possible.

Position Qualifications (Preferred):
  • Technical background in engineering (Bsc.)
  • Experience with combination product LCM and design controls
  • Experience in biotech/pharmaceutical or medical device company
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